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There is a sentence in the EU's General Product Safety Regulation that this blog has come back to more than any other: GPSR is residual. It applies where no more specific EU law does. We worked through what that means for an eyewear catalogue in Sunglasses Are PPE. Your Frames Are a Medical Device. — frames, prescription lenses, readers and contact lenses are medical devices under the EU Medical Device Regulation, so they fall out of general product safety law and into a much heavier regime.
Britain is now writing its own version of that law, and it has drafted the same carve-out. The proposed new UK framework would apply to all products with specific exceptions, and one of the exceptions is medicines and medical devices.
Same sentence. Different hole. Because Great Britain does not agree with the European Union about which eyewear products are medical devices in the first place.
What has actually happened, and what has not
Take the status seriously before the substance, because the substance is not law yet and a lot of the commentary reads as though it were.
The Product Regulation and Metrology Act 2025 received Royal Assent in July 2025. It is an enabling Act: it does not itself impose duties on sellers, it gives ministers the power to make regulations that do. The question has always been what those regulations would say.
On 13 April 2026, in a written ministerial statement, the government announced the consultations that answer it. The statement is blunt about the target: “For too long, online marketplaces have made third party sales of dangerous products too easy.” It confirmed that “we are consulting on proposals to introduce new requirements on online marketplaces and create a level playing field”, and that “These consultations will close after 12 weeks on 23 June 2026.”
The main consultation, The UK’s new product safety framework, opened at midday on 31 March 2026 and closed at 11:59pm on 23 June 2026.
As of today, the GOV.UK page says “We are analysing your feedback.” There is no published government response. There are no draft regulations. There is no date.
That matters, and it is the reason this post is written the way it is. Three months after a twelve-week consultation closed, the shape of a regime that would reach every consumer product sold in Great Britain is still a set of proposals. Nothing below binds you today. All of it is worth reading today, because the thing being decided is which pile your catalogue goes in — and that question is nearly settled by drafting decisions already made elsewhere.
The carve-out, and why it does the opposite of what you would expect
Both regimes do the same tidy thing. General product safety law is the backstop; where a specialised regime already governs a product, the backstop steps aside. The EU says GPSR is residual. The UK consultation proposes that “the new framework will apply to all products, with some specific exceptions”, and lists among those exceptions medicines and medical devices, alongside food, animals, military equipment, most aircraft, antiques and artworks.
Read in isolation, those two designs look identical. They produce opposite answers for an eyewear store, because the word doing the work — medical device — does not mean the same thing on the two sides of the Channel.
Here is the MHRA’s own guidance, Borderlines with medical devices and other products in Great Britain, updated 29 June 2026. Among the products it lists as falling outside the medical devices regime:
“Non-prescription sunglasses, spectacles and contact lenses (unless there is another medical purpose assigned to them by the manufacturer)”
And the principle behind it:
“Products that do not have such a principal intended purpose are not considered to be medical devices, even if they may be considered to be used for the prevention of disease”
Now set that against Europe. The EU Medical Device Regulation has Annex XVI, a list of products with no intended medical purpose that are regulated as devices anyway. Point 1 of that Annex is contact lenses and other items intended to be introduced into or onto the eye. We wrote that up in Those Halloween Lenses Need a Prescription in America and a Notified Body in Europe. Annex XVI is a creation of the 2017 Regulation. Great Britain’s medical devices law is still the Medical Devices Regulations 2002, which implement the older European directives — and those directives had no Annex XVI.
So the coloured, zero-powered lens you sell for Halloween:
- In the EU, it is a medical device. It needs a notified body. It is out of GPSR.
- In Great Britain, it is not a medical device. So the medical-devices carve-out does not catch it — which means it would sit squarely inside the proposed new general product safety framework.
The same is true of non-prescription sunglasses, which the MHRA guidance names in the same breath. In the EU those are personal protective equipment under Regulation (EU) 2016/425 — the point that makes marketing UV protection as a feature a blacklisted practice, as covered in the green-claims post. In Great Britain they are neither a medical device nor, on this guidance, anything else in particular. They are a product.
Where your catalogue lands, line by line
| Product | European Union | Great Britain (proposed) | Same answer? |
|---|---|---|---|
| Prescription spectacles, glazed to order | Medical device under MDR; out of GPSR | Medical device under the 2002 Regulations; out of the new framework | Yes |
| Prescription contact lenses | Medical device; out of GPSR | Medical device; out of the new framework | Yes |
| Ready-made reading glasses | Medical device under MDR | Turns on the purpose the manufacturer assigns | Open |
| Coloured / zero-powered cosmetic lenses | Medical device via MDR Annex XVI point 1 | Not a medical device — so in the new framework | No |
| Non-prescription sunglasses | PPE under Reg. (EU) 2016/425 | Not a medical device — so in the new framework | No |
| Empty spectacle case, cloth, cord | GPSR | In the new framework | Yes |
| Smart or audio frames, no correction | Several regimes at once; not MDR on that basis alone | In the new framework, plus electrical rules | Broadly |
The interesting rows are the two that say No, and they have something in common. They are the products with no medical purpose. Europe reached out and pulled them into its device regime anyway. Britain left them where they were. The result is that the part of an eyewear catalogue with the least clinical content is the part where the two jurisdictions diverge most — and it is also, for a lot of stores, the part with the highest volume and the thinnest margin.
The tenth line, and it is drawn somewhere new
Readers who have followed this blog through the year will recognise the exercise. Every regime we have looked at draws its decisive line somewhere, and the somewhere is rarely where you would guess: what the object is, what the store did to it, where the checkout renders, whose hands it passed through, who is made liable for the debt.
This one draws the line by what the neighbouring regime happens to catch.
Nothing in the proposed UK framework says anything about eyewear. It says “medical devices” and stops. Whether your product is inside or outside is then decided entirely by a different statute, written for a different purpose, at a different time — and in this case, a statute that is twenty-four years old and predates the European provision that would have answered the question the other way.
Which gives the practical rule worth taking away from this post, and it generalises well beyond Britain: when a rule carves out another regime’s products, find out which jurisdiction’s version of that other regime you are reading, and how old it is. An exclusion is only as stable as the definition it points at. Two identical carve-outs can leave two very differently shaped holes.
What the framework would actually require
For products that land inside it, the consultation proposes to keep the familiar test of a safe product — one presenting “any risk or only the minimum risks compatible with the product’s use” — and says “we propose retaining this definition of a safe product in the new framework”.
The duties attach by role. Producers would be “prohibited from supplying or offering to supply a product unless it is safe”. Onward suppliers must “act with due care and not supply a product unless it is compliant”.
And here is the provision a direct-to-consumer store selling into Britain should read twice. Where the manufacturer is not UK-based and there is no UK representative, the consultation proposes that “the person making the offer to supply the product… such as an overseas seller” is the producer.
Read that as what it is. If you are an eyewear brand outside the UK shipping coloured lenses or sunglasses direct to British consumers from your own website, and there is nobody in the UK standing between you and the buyer, the proposal makes you the producer of that product — with the producer’s duty, not the supplier’s lighter one. This is the same structural move Britain made in its customs reform, where a UK-based business is made jointly liable for an overseas seller’s import duty; we covered that in the low-value imports post. Two different departments, two different instruments, one consistent instinct: there should be somebody in Britain who answers for this.
The consultation also floats a “requirement for a responsible person based in the UK” which “may be appropriate for some high-risk products”, with foreign sellers expected to “appoint an authorised representative or reach an agreement with an importer of their products”. Note the hedge — may be appropriate, some high-risk products. Nothing there tells you whether eyewear would be on that list. Do not assume either way.
If you sell through a marketplace, this is the section
The marketplace proposals are the most developed part of the package, and they change the economics of platform selling before they change the law.
The core proposed duty is that online marketplaces “act with due care to prevent, identify and remove dangerous products being made available on their platforms”. Underneath it sit specifics:
- “Conducting risk-based targeted monitoring of their platforms to identify products that are non-compliant”
- “Putting in place processes to prevent non-compliant products being listed”
- “Developing a product safety plan”
- Due diligence “to identify and take action against ‘bad actors’”
- A duty to “verify seller contact details”
- A duty to cooperate with authorities, and to “register the single point of contact with relevant authorities”
None of those is a duty on you. Every one of them becomes a condition on you, because a platform facing a due-care duty and a monitoring obligation does not absorb that risk — it pushes it down into seller onboarding. The practical translation for an eyewear seller on a marketplace is more documentation demanded at listing time, faster and more automated takedowns, and far less patience with a category that looks risky.
Coloured contact lenses look risky. They are going into somebody’s eye, they are sold on appearance, they have a documented history of harm, and — per the section above — in Great Britain they carry no device approval to point at. A marketplace running risk-based monitoring will find that category early. If a meaningful share of your UK volume is cosmetic lenses sold through a platform, the listing conditions are likely to move before the law does.
There is a related point about where a sale is treated as happening when a platform or an agent stands in the middle, which we worked through in the agentic commerce post.
The thing that could turn this on its head
One development could unmake the whole argument above, and it is worth watching rather than worrying about.
The MHRA published a draft Medical Devices (Amendment) Regulations 2026 on the WTO notification portal on 8 May 2026, expected to be adopted in December 2026 and to come into force in June 2027, subject to Parliament. The MHRA has separately been considering, since a 2021 consultation, whether to extend the UK regime to products with no intended medical purpose — the Annex XVI idea — and coloured lenses were expressly named in that discussion.
We have not established whether the draft 2026 amendment does that, and we are not going to assert that it does or does not. What we can say is precise: the MHRA guidance in force and updated on 29 June 2026 says non-prescription lenses are not medical devices in Great Britain. If a future instrument changes that, then the same product moves out of the new product safety framework and into the devices regime — without a word of the product safety framework changing.
Which is the whole point of this post, demonstrated on itself. The exclusion is stable. The thing it points at is not.
Northern Ireland
Short section, and it is the reason we have said “Great Britain” throughout rather than “the UK”. The MHRA guidance quoted above is expressly about Great Britain. Northern Ireland’s position on goods regulation follows a different arrangement, and the EU rules — including MDR and its Annex XVI — have effect there in a way they do not in England, Scotland and Wales. If you ship to Belfast as well as Birmingham, do not assume one answer covers both. We have not worked through the Northern Ireland position and this post does not attempt to.
What to do now
- Split your catalogue by the medical-device question, per market. Not by product type — by whether the product is a device in that jurisdiction. The rows in the table above that say No are the ones to list.
- Work out what share of your UK revenue is non-prescription. Cosmetic lenses, plano sunglasses, accessories. That is your exposure to the new framework, and it is a number most eyewear stores have never calculated separately.
- If you sell through a marketplace, ask now what is coming. Seller onboarding requirements move on platform timelines, not parliamentary ones.
- Find out who your UK-facing producer is. If you ship direct from outside the UK with no UK importer or representative, the proposal points at you. Knowing that before it is law is worth more than reacting after.
- Keep your technical documentation retrievable. Whatever the framework ends up requiring, it will require evidence, and gathering it from suppliers takes months.
- Watch two things and only two. The government response to the 23 June consultation, and the Medical Devices (Amendment) Regulations 2026. One decides the rules; the other decides which of your products they apply to.
- Do not rewrite anything yet. There are no duties here to comply with today, and a store that rebuilds its listings against a consultation document will do it twice.
Where none of this reaches
Notice which half of an eyewear store this lands on, because the pattern is by now familiar.
Everything above attaches to the object — what it is, which regime claims it, who is deemed to have produced it, which platform listed it. The prescription step is untouched. Sphere, cylinder, axis, add, PD; single vision or progressive; index, coating, tint. Capturing a prescription accurately is not a product safety question and no framework proposed here changes how you do it.
There is a quiet irony worth noticing on the way out. The products in your catalogue that carry the most regulation — the glazed prescription pair — are the ones this new framework will not touch at all, in either jurisdiction. The ones that carry the least are where Britain and Europe have now split. The compliance risk in eyewear does not track the clinical risk. It never has.
Frequently asked questions
Is any of this law yet?
No. The Product Regulation and Metrology Act 2025 is in force, but it is enabling legislation. The framework described here is a consultation that closed on 23 June 2026 and has not yet received a government response. There is no draft instrument and no commencement date.
So why read it now?
Because the consultation tells you which pile your products are being sorted into, and that sorting is already effectively decided by the MHRA guidance and the age of the UK devices regime. The rules can change; the classification question is here now.
Are prescription glasses medical devices in Great Britain?
The MHRA guidance lists non-prescription sunglasses, spectacles and contact lenses as products outside the devices regime, which reads as implying prescription ones are inside it, and that is the long-standing understanding. We are stating the implication rather than a quoted rule, because the guidance states the exclusion and not the inclusion. Check your own products against the guidance.
Are coloured contact lenses unregulated in Great Britain, then?
Not unregulated — differently regulated. They are not medical devices on this guidance, which is why they would fall inside the proposed general product safety framework rather than outside it. Separate rules about who may sell and supply contact lenses in the UK are a different body of law from product safety and are outside the scope of this post.
I sell into the UK from the EU. Does the EU answer travel with the product?
No. Classification is decided by the law of the market you sell into. A lens that is a medical device when it leaves Rotterdam is not one when it arrives in Manchester, on this guidance. This is the same principle as everywhere else in this series: the market you sell into sets the rules, not the market you sit in.
Does this replace the existing UK product safety rules?
The proposal is to build a new core framework and a new market surveillance and enforcement regime, consulted on together. Until a response and then regulations appear, the current rules continue to apply.
What about Northern Ireland?
Different arrangement, different answer, and this post does not cover it. See the section above.
Will marketplaces start asking me for more paperwork?
That is the most likely first consequence and the one that does not wait for legislation. Platforms facing a proposed due-care and monitoring duty tend to tighten seller requirements ahead of the rules, not after them.
This article is general information about regulatory developments as they stood on 27 September 2026, not legal advice, and it does not describe VisioncarePro’s own compliance status. The UK framework described here is a closed consultation with no published government response, no draft regulations and no commencement date; nothing in it imposes a duty today. The classification points rest on MHRA guidance updated 29 June 2026, which is guidance rather than legislation. We have not established the content of the draft Medical Devices (Amendment) Regulations 2026 on products without an intended medical purpose, and assert nothing about it. The Northern Ireland position is not covered. Take advice on your own catalogue and markets before acting.
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Sources: Product Regulation and Metrology Act 2025 (c. 20) · GOV.UK consultation, Product regulation: the UK’s new product safety framework, opened midday 31 March 2026, closed 11:59pm 23 June 2026, status “We are analysing your feedback” · GOV.UK consultation, Product regulation: market surveillance and enforcement framework, same dates and status · Written Ministerial Statement HCWS1496, 13 April 2026 · MHRA, Borderlines with medical devices and other products in Great Britain, updated 29 June 2026 · Regulation (EU) 2017/745 (MDR), Annex XVI point 1 · Regulation (EU) 2023/988 (GPSR), Article 2(1) · Regulation (EU) 2016/425 on personal protective equipment · Medical Devices Regulations 2002 (SI 2002/618) · draft Medical Devices (Amendment) Regulations 2026, notified 8 May 2026, adoption expected December 2026 and entry into force expected June 2027 · MHRA consultation on the future regulation of medical devices in the United Kingdom (2021), on products without an intended medical purpose.
